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Prevents disseminated Mycobacterium avium complex (MAC) disease. NDA 50689, held by Pfizer. Rifabutin.
As of Nov 13, 2026, NDA 50689 (Mycobutin), held by Pfizer, was first approved by FDA on Dec 23, 1992, with 19 approved supplements and 0 published complete response letters.
First approved: Dec 23, 1992
Review: Priority
Supplements approved: 19
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
